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Shall HTA Depend on Randomised Controlled Trials (RCT) or Real-World Data (RWD) or Both?
Session Chair(s)
Luca Pani, MD
Former, AIFA; Professor, Department of Psychiatry and Behavioral Sciences, University of Miami, United States
Shall HTA Depend on Randomised Controlled Trials (RCT) or Real-World Data (RWD) or Both?
Learning Objective : • To understand how regulatory, payer, healthcare professional and patient stakeholders value and use patient-reported outcome endpoints. • To understand the methods and timings for developing a robust, comprehensive and systematic PRO endpoint strategy that can meet the needs of all stakeholders in a single lifecycle program for a medication
Speaker(s)
Chris Chinn, MSc
Real World Evidence for Market Access, Sanofi, United Kingdom
Giovanni Tafuri, PhD, MS
Senior Scientific Officer, EUnetHTA, Netherlands
Applying RCT Standards to RWD: Experiences with Post-Authorisation Efficacy Studies (PAES)
François Meyer, MD
Advisor to the President, International Affairs, French National Authority for Health (HAS), France
Conducting HTA Using RWD
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